ISO 15189:2022

Medical laboratories — Requirements for quality and competence

This document specifies requirements for quality and competence in medical laboratories.

This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

This document is also applicable to point-of-care testing (POCT).

NOTE??????????? International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

Edition	2022
Published Date	2022
Published By	International Standardization Organisation
Page Count	62